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Comprehensive and up-to-date drug news for both consumers and healthcare professionals.

Health Highlights: Aug. 23, 2016

Posted yesterday in Medical

Here are some of the latest health and medical news developments, compiled by the editors of HealthDay: Congress Questioning EpiPen Price Hike Members of Congress want the maker of EpiPens to explain why the price of the lifesaving product has risen 400 percent since 2007 and now costs as much as $600. An EpiPen delivers a potentially life-saving injection of medicine into people suffering a severe allergic...

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Health Tip: Explaining Circuit Training

Posted today in Medical

-- Circuit training offers a fast-paced exercise regimen that moves quickly between different stations designed to work different areas of your body. The American Council on Exercise explains why it's a good choice: Circuit training combines both cardiovascular and strengthening exercises in one workout. Because there are so many different exercises, it helps prevent boredom. It burns a high amount of calories. You...

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Health Tip: Losing Hair After Pregnancy

Posted today in Medical

-- Hormonal changes cause some new moms to lose hair after pregnancy. But there are things women can do to help their hair look fuller. The American Academy of Dermatology suggests: Shampooing with a volumizing product. Skipping conditioning shampoos, which add weight to hair. Opting for a lighter conditioner that's designed for fine hair. Apply it only on the ends of the hair and avoid the scalp.

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Five More Cases of Local Zika Infection Reported in Florida

Posted today in Medical

TUESDAY, Aug. 23, 2016 -- Five more cases of locally transmitted Zika infection were confirmed by Florida health officials on Tuesday, including one in the Tampa Bay area. The four other cases were connected to mosquitoes in Miami's Wynwood arts district, the first area in Florida to report local transmission of Zika. According to the Florida Department of Health, the fifth was diagnosed in a Pinellas County...

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FDA Accepts Clovis Oncology’s NDA for Rucaparib for Priority Review for the Treatment of Advanced Mutant BRCA Ovarian Cancer

Posted today in New Drug Applications

BOULDER, Colo.--(BUSINESS WIRE)--Aug. 23, 2016-- Clovis Oncology, Inc. (NASDAQ: CLVS) announced today that the U.S. Food and Drug Administration (FDA) has accepted Clovis’ New Drug Application (NDA) for accelerated approval of rucaparib and granted priority review status to the application with a Prescription Drug User Fee Act (PDUFA) date of February 23, 2017. In late June 2016, Clovis completed its NDA submission o...

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Congress Questioning EpiPen Price Hike

Posted today in Medical

Members of Congress want the maker of EpiPens to explain why the price of the lifesaving product has risen 400 percent since 2007 and now costs as much as $600. An EpiPen delivers a potentially life-saving injection of medicine into people suffering a severe allergic reaction. In a letter to the pharmaceutical company Mylan, Senator Charles Grassley, the Iowa Republican who heads the Judiciary Committee, demanded...

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FDA Approves Troxyca ER (oxycodone hydrochloride and naltrexone hydrochloride) Capsules with Abuse-Deterrent Properties for the Management of Pain

Posted 5 days ago in New Drug Approvals

Friday, August 19, 2016 -- Pfizer Inc. (NYSE:PFE) announced today that the U.S. Food and Drug Administration (FDA) has approved Troxyca ER (oxycodone hydrochloride and naltrexone hydrochloride) extended-release capsules, for oral use, CII for the management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate. Troxyca ER has...

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Portola Pharmaceuticals Receives Complete Response Letter from FDA for Biologics License Application for AndexXa (andexanet alfa)

Posted 6 days ago in New Drug Applications

SOUTH SAN FRANCISCO, Calif., Aug. 17, 2016 (GLOBE NEWSWIRE) -- Portola Pharmaceuticals Inc.® (NASDAQ:PTLA) today announced that it has received a Complete Response Letter (CRL) from the U.S. Food and Drug Administration (FDA) regarding its Biologics License Application (BLA) for AndexXa™ (andexanet alfa). An FDA-designated Breakthrough Therapy, AndexXa is in development for patients treated with a direct (apixaban, r...

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Heron Therapeutics Announces FDA Approval of Sustol (granisetron) Extended-Release Injection for the Prevention of Chemotherapy-Induced Nausea and Vomiting

Posted 13 days ago in New Drug Approvals

REDWOOD CITY, Calif.--(BUSINESS WIRE)--Aug. 10, 2016-- Heron Therapeutics, Inc. (NASDAQ:HRTX), today announced that the U.S. Food and Drug Administration (FDA) has approved Sustol (granisetron) extended-release injection. Sustol is a serotonin-3 (5-HT3) receptor antagonist indicated in combination with other antiemetics in adults for the prevention of acute and delayed nausea and vomiting associated with initial and...

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FDA Accepts Marathon Pharmaceuticals’ NDA for Deflazacort for the Treatment of Duchenne Muscular Dystrophy

Posted 2 weeks ago in New Drug Applications

Northbrook, Ill. – August 10, 2016 – Marathon Pharmaceuticals, LLC, a biopharmaceutical company developing treatments for rare diseases, today announced the New Drug Applications (NDA) for the investigational drug deflazacort have been accepted for filing and granted Priority Review by the U.S. Food and Drug Administration (FDA). The NDAs (one for immediate-release tablet formulations and one for an oral suspension f...

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Pfizer Announces Publication of New Analysis Showing Long-Term Therapy with Vyndaqel (tafamidis) Slowed Progression of Rare Neurodegenerative Disease

Posted 2 weeks ago in New Drug Applications

August 8, 2016 - Pfizer Inc. (NYSE:PFE) announced the publication of a new post-hoc analysis of data from three studies of Vyndaqel in patients with mild transthyretin familial amyloid polyneuropathy (TTR-FAP). The analysis, which included patients with the Val30Met mutation treated over varying periods of up to 5.5 years, showed that treatment with Vyndaqel initiated during the early stage of the disease resulted...

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FDA Approves Merck’s Keytruda (pembrolizumab) for Patients with Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma

Posted 2 weeks ago in New Drug Approvals

KENILWORTH, N.J.--(BUSINESS WIRE)--August 5, 2016 Merck (NYSE:MRK), known as MSD outside the United States and Canada, today announced that the U.S. Food and Drug Administration (FDA) has approved Keytruda (pembrolizumab), the company’s anti-PD-1 (programmed death receptor-1) therapy, at a fixed dose of 200 mg every three weeks, for the treatment of patients with recurrent or metastatic head and neck squamous cell c...

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Merck Announces U.S. FDA Filing Acceptance of New Drug Application (NDA) for MK-1293, an Investigational Follow-On Biologic Insulin Glargine

Posted 2 weeks ago in New Drug Applications

KENILWORTH, N.J.--(BUSINESS WIRE), August 5, 2016 --Merck (NYSE:MRK), known as MSD outside of the United States and Canada, today announced that the U.S. Food and Drug Administration (FDA) has accepted for review the New Drug Application (NDA) for MK-1293, an investigational follow-on biologic1 insulin glargine candidate for the treatment of people with type 1 and type 2 diabetes, which is being developed by Merck...

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FDA Approves First Generic Version of Widely Used Influenza Drug Tamiflu

Posted 2 weeks ago in Pharma Industry News

On August 3, 2016, the U.S. Food and Drug Administration approved the first generic version of Tamiflu (oseltamivir phosphate), a widely used medication for the treatment of the flu (influenza A and B) in patients two weeks of age and older who have had flu symptoms for no more than 48 hours; and prevention of the flu in patients one year of age and older. Tamiflu was approved in 1999. The FDA is committed to...

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Kratom Seized in California by US Marshals Service

Posted 2 weeks ago in Pharma Industry News

August 4, 2016 -- The U.S. Food and Drug Administration announced today that the U.S. Marshals Service seized more than 100 cases of products labeled as containing kratom. The products are distributed by Nature Therapeutics LLC, which does business as Kratom Therapy and is located in Grover Beach, California. The seized products are marketed under the brand name Kratom Therapy, and are worth approximately...

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FDA Approves Flonase Sensimist Allergy Relief

Posted 3 weeks ago in New Drug Approvals

WARREN, N.J. 2 August 2016 -- GSK Consumer Healthcare announced today that the U.S. Food and Drug Administration (FDA) has approved Flonase® Sensimist™ Allergy Relief (fluticasone furoate, 27.5 mcg spray) as an over-the-counter (OTC) treatment for symptoms associated with seasonal and perennial allergies. Previously available by prescription as Veramyst®, Flonase Sensimist is the latest Rx-to-OTC switch from GSK...

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Ipsen Biopharmaceuticals, Inc. Announces FDA Approval of Dysport (abobotulinumtoxinA) for the Treatment of Lower Limb Spasticity in Pediatric Patients Aged Two and Older

Posted 3 weeks ago in New Drug Approvals

BASKING RIDGE, N.J., Aug. 1, 2016 /PRNewswire/ -- Ipsen Biopharmaceuticals, Inc., a subsidiary of Ipsen SA (Euronext: IPN; ADR: IPSEY) (Ipsen), today announced that the U.S. Food and Drug Administration (FDA) has approved its supplemental Biologics License Application (sBLA) for Dysport® (abobotulinumtoxinA) for injection for the treatment of lower limb spasticity in pediatric patients two years of age and older. ...

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Monthly News Roundup - July 2016

Posted 3 weeks ago in Pharma Industry News

Injectable Adlyxin FDA-Approved for Type 2 Diabetes The FDA has approved Sanofi’s Adlyxin (lixisenatide), a new once-daily injectable type 2 diabetes medication. Adlyxin is classified as an incretin mimetic/GLP-1 receptor agonist. For maintenance dosing, Adlyxin will be available in a disposable pre-filled pen of 20 micrograms. Adlyxin is given at mealtime and used alongside diet and exercise to improve blood s...

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FDA Updates Warnings for Fluoroquinolone Antibiotics

Posted 4 weeks ago in Pharma Industry News

July 26, 2016 -- The U.S. Food and Drug Administration today approved safety labeling changes for a class of antibiotics, called fluoroquinolones, to enhance warnings about their association with disabling and potentially permanent side effects and to limit their use in patients with less serious bacterial infections. “Fluoroquinolones have risks and benefits that should be considered very carefully,” said Edward Co...

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FDA approves first absorbable stent for coronary artery disease

Posted 7 weeks ago in Pharma Industry News

July 5, 2016 -- The U.S. Food and Drug Administration today approved the first fully absorbable stent to treat coronary artery disease. The Absorb GT1 Bioresorbable Vascular Scaffold System (BVS), which releases the drug everolimus to limit the growth of scar tissue, is gradually absorbed by the body in approximately three years. “The FDA’s approval of the Absorb GT1 BVS offers a new treatment option for ind...

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AstraZeneca and Lilly Receive FDA Fast Track Designation for AZD3293, an Investigational Treatment for Early Alzheimer’s Disease

Posted 2 days ago in Clinical Trials

22 August 2016 -- AstraZeneca and Eli Lilly and Company (Lilly) today announced they have received US Food and Drug Administration (FDA) Fast Track designation for the development programme in Alzheimer’s disease for AZD3293, an oral beta secretase cleaving enzyme (BACE) inhibitor currently in Phase III clinical trial. The FDA’s Fast Track programme is designed to expedite the development and review of new therapies ...

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Juniper Pharmaceuticals Reports Results from Phase 2b Clinical Trial of COL-1077 Lidocaine Vaginal Gel in Gynecologic Procedure Pain

Posted 6 days ago in Clinical Trials

BOSTON, Aug. 17, 2016 /PRNewswire/ -- Juniper Pharmaceuticals, Inc. (Nasdaq: JNP) ("Juniper" or the "Company"), a women's health therapeutics company, today announced that a recently completed Phase 2b clinical trial evaluating its 10% lidocaine bioadhesive vaginal gel, COL-1077, for the reduction of pain intensity in women undergoing an endometrial biopsy with tenaculum placement did not achieve its primary and...

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Cytokinetics Completes Enrollment in VITALITY-ALS, Phase 3 Clinical Trial of Tirasemtiv in Patients with ALS

Posted 7 days ago in Clinical Trials

SOUTH SAN FRANCISCO, Calif., Aug. 17, 2016 (GLOBE NEWSWIRE) -- Cytokinetics, Inc. (Nasdaq:CYTK) today announced the completion of patient enrollment in VITALITY-ALS (Ventilatory Investigation of Tirasemtiv and Assessment of Longitudinal Indices after Treatment for a Year in ALS), an international Phase 3 clinical trial of tirasemtiv in patients with ALS. VITALITY-ALS is designed to assess the effects of tirasemtiv...

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Tivorsan Pharmaceuticals Granted FDA Orphan Drug Designation for Human Recombinant Biglycan in the Treatment of Duchenne Muscular Dystrophy

Posted 7 days ago in Clinical Trials

PROVIDENCE, R.I.–(BUSINESS WIRE)– August 15, 2016 -- Tivorsan Pharmaceuticals, Inc., a biotechnology company that is pioneering a novel approach to treating all forms of Duchenne Muscular Dystrophy (DMD) and other serious, debilitating neuromuscular disorders, today announced that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation to its lead investigational drug, human recombinant Big...

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ViiV Healthcare Launches Phase III Programme Evaluating a Two-Drug Regimen Combining Dolutegravir and Lamivudine for HIV-1 Treatment

Posted 8 days ago in Clinical Trials

16 August 2016 -- ViiV Healthcare today announced the start of a phase III programme to support regulatory filings for a two-drug regimen of dolutegravir (Tivicay®) and lamivudine (Epivir®) as a treatment for HIV-1 infection in adults who have not received prior antiretroviral therapy. The phase III programme comprises two identical studies (GEMINI 1 and 2) comparing a two-drug regimen of dolutegravir plus l...

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